Food Safety Modernization Act
One last chance to comment
If a grower buys and sells fresh produce typically consumed raw, like apples, from another farm, then he or she would be considered a food facility as well as a farm, and therefore subject to the preventive controls rule. Comments on the two rules that will affect fruit and vegetable growers must be submitted to the FDA by November 15, 2013.
Photos by Vern Grubinger.
For many years, foods that pose significant safety risks if not properly handled have been highly regulated, including dairy, meat and seafood. Fruits and vegetables don't pose nearly as much risk, so growers haven't had to deal with food safety regulations aimed at fresh produce. Some growers voluntarily complied with Good Agricultural Practices (GAP) in order to satisfy their markets, but for the most part, the industry was left to take common-sense precautions to keep produce safe.
With Congress passing the Food Safety Modernization Act (FSMA), that situation has changed. Once implemented, this federal law will require many growers to spend a lot of time and resources on risk prevention. Even growers exempted from the law are likely to be affected, because over time food buyers will want documentation of similar food safety practices from all the farms they deal with.
According to the Centers for Disease Control and Prevention (CDC), about 48 million Americans get sick and 3,000 die each year from foodborne diseases. However, little of this is due to fresh produce. For example, from 1996 to 2010, there were 131 produce-related outbreaks resulting in 14,350 illnesses and 34 deaths. Thus, fresh produce accounts for about 1 percent of all foodborne disease-related deaths. While this is tragic and growers agree that more can be done to reduce food safety risks on their farms, it should be recognized that millions of pounds of fresh produce are consumed every day with hardly any problems. That said, FSMA is now the law, and growers will have to deal with its requirements, aimed at making a small risk even smaller.
The law and the rules
The FSMA law provides the framework for new food safety regulations, called rules. These are written after a law is passed, and they provide the specifics of how it will work. FSMA put the U.S. Food and Drug Administration (FDA) in charge of regulating food safety on produce farms, rather than the U.S. Department of Agriculture (USDA), which has typically regulated farm practices.
There are a variety of rules associated with FSMA, but two in particular specify what will be required of growers: the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (produce safety rule); and Preventive Controls for Human Food (preventive controls rule).
The draft rules are long, complicated documents, but there are many summaries available online. A good place to start is the FDA's website: http://www.fda.gov/Food/GuidanceRegulation/FSMA. For summaries of the different sections of the rule online, visit:
National Sustainable Agriculture Coalition: http://sustainableagriculture.net/fsma
University of New Hampshire Cooperative Extension: http://extension.unh.edu/Food-Safety-Modernization-Act-FSMA
New England Farmers Union: http://www.newenglandfarmersunion.org/food-safety-modernization-act
Don't miss the deadline
The deadline to submit comments to the FDA on the draft FSMA rules has been extended twice, to November 15, 2013. After that the FDA will finalize the rules, though it will be a few years before they're implemented. Take the time to learn how the rules will affect your farm, and then submit your comments online.
Below are some key concepts about the proposed rule, and I have listed some specific concerns and suggestions. These are my personal opinions, not those of any organization I work for. Take time to develop your own views on these issues.
Farm versus facility
The produce safety rule applies to farms that grow, harvest, pack or hold what is termed "covered" produce. The preventive controls rule applies to facilities that manufacture, process, pack or hold human food, and those that buy and resell products grown on other farms. These facilities must register with the federal government. If you only grow, wash and trim off outer leaves, and if you only sell products you grow, then you run a farm and the preventive controls rule does not apply to you. However, if you peel, chop, combine ingredients, or buy and resell products from another farm, you run a facility or a mixed farm facility and you may be subject to this rule.
Facilities have to keep a written food safety plan, including a hazard analysis, and they will be required to keep records of preventive controls, monitoring, corrective actions and verification. There is still some confusion about what activities make a farm into a facility. Further, the scale of production that triggers designation as a facility and associated requirements is not yet set; exemptions up to $25,000 or even $500,000 have been suggested.
Many farms buy and resell products from other farms. Quite a few farms lightly process vegetables or do on-farm value-added processing. Even a minimal amount of additional paperwork will deter farms from engaging in these activities, which have been encouraged as ways to strengthen local food systems. Only farms that conduct these activities with large volumes of produce - over $1 million of sales to wholesale markets - should be regulated as facilities. Buying fresh produce in clearly labeled containers from other farms that have their own food safety plan does not increase food safety risks enough to warrant the buying farm coming under the preventive controls rule.
Covered produce is generally eaten raw, such as leafy greens, melons, tomatoes, etc. The produce safety rule does not apply to produce that is usually cooked, such as asparagus, beets, potatoes, pumpkins and sweet corn. It also does not apply to produce grown for personal consumption or consumption on the farm.
Buyers are not likely to distinguish between covered and noncovered produce and will want to see evidence of food safety risk management on all farms they purchase from. Further, since most farms grow, harvest and pack a mixture of covered and noncovered produce, these categories complicate the rule without providing significant regulatory relief to most farms. The rule requires careful separation of covered and noncovered produce. It would be simpler for the marketplace and diversified farms if FSMA simply applied to fresh produce.
Cost to growers
The FDA developed estimates for the cost of FSMA implementation. For farms with total food sales between $25,000 and $250,000, the cost is approximately $5,000 per year; farms with sales between $250,000 and $500,000 could spend about $13,000 per year; and for farms with sales over $500,000, the cost is estimated at $30,000 per year.
These are large expenses for small and medium-sized farms, especially when you consider that food sales include all types of food, while the costs are incurred only for covered produce, which may be a fraction of a farm's total food sales. For example, many farms in my area gross just over $500,000 in food sales, and their covered produce accounts for perhaps half of that. A $30,000 hit will take a large part of their net revenues.
These high costs, in combination with the management burden of compliance, are likely to drive many small and medium growers out of the fresh produce business. It will be simpler to not grow fruits or vegetables and just have a store that sells other farms' products. Even though many farms that sell retail or directly to retailers will be exempt from FSMA, they are likely to have similar costs if their customers or insurance agents demand analogous food safety documentation. These costs will hinder the development of local food systems that provide economic development, food security and access to fresh food for communities across the nation.
Produce safety rule
In a nutshell, this rule establishes standards for agricultural water; biological soil amendments of animal origin; domesticated and wild animals; equipment, tools and buildings; health and hygiene; and training.
Some farms will be exempt from the produce safety rule. If you don't grow any covered produce, you are exempt. Other farms are exempted based on their level of total food sales (all human and animal foods, including eggs, hay, meat, milk, pickles and all covered and noncovered fruits and vegetables). Farms that have less than $25,000 in total food sales per year averaged over three years are exempt from this rule. Farms that have food sales between $25,000 and $500,000 are exempt only if over half of all their food sales are directly to consumers, restaurants and certain retailers within 275 miles of the farm. However, these farms must still comply with certain labeling practices.
There are numerous concerns with exemptions. First is the use of all food rather than covered produce as a basis for determining an exemption. This definition is in the FSMA law, not the draft rule, so the FDA cannot change it, but if you think it should be changed, let them know and copy your federal legislators. This definition will create situations where farms that sell only a small amount of fresh produce will have to comply with the law. Exemptions should be based on annual sales of covered produce only. Also, it is not clear how farmers working together in cooperatives or food hubs would be affected; this rule could deter farmers from working together to market their crops if it puts them over the threshold for exemption.
A system that lets some growers do nothing and requires others to do more than necessary does not make sense. Food safety would be better accomplished by a simpler method of tiered compliance, as is used in other areas of risk management regulation, from water supplies to airplane safety. All farms should have a food safety plan, and for the vast majority of farms (which are small farms), this should be simple and highly practical.
For example, all farm employees should wash their hands before handling produce, and raw manure should not be applied on any farms without a reasonable delay before harvest. Small farms could have a checklist type of plan that assures they employ the most critical food safety practices.
The largest farms warrant a more complicated approach like that proposed in the draft rules. Large farms pose most of the fresh produce food safety risk, given the volume of produce they sell and its wide geographic distribution.
The smallest tier of farms - under $100,000 in annual sales of fresh produce - should be required to have a simple food safety plan on file at the farm; farms from there up to $1 million in fresh produce sales should be regulated by state agencies that can provide them with locally appropriate food safety plan templates, such as those already developed by cooperative extension in some states. Only farms selling $1 million or more of fresh produce into wholesale food channels should be required to comply with FSMA. This is a more realistic approach in terms of implementation cost, and it will be more effective in protecting food safety, since it would help all growers identify and act on the most important food safety risks on their farms, rather than tying them up with record-keeping. This approach will also ensure that the effort and cost required are proportional to the risk. Further, it will provide assurance to buyers that all growers have a food safety plan.
The draft produce safety rule requires waiting nine months after applying uncomposted manure before harvesting a crop that is typically eaten raw. This is a lot longer than the four-month maximum wait currently required by the National Organic Standards.
Agricultural water is water that's intended to contact covered produce. It includes water used for overhead irrigation, crop sprays, and washing, wetting or icing during harvesting, packing and holding. Water that does not have the potential to come in direct contact with covered produce is not subject to this rule, including subsurface drip irrigation water. Agricultural water from streams, lakes, rivers, ponds, etc., must be tested at least every seven days for generic E. coli. This water cannot be used if the average of five samples exceeds 126 colony-forming units (CFU) per 100 milliliters of water or if one sample is above 235 CFU.
The testing requirements for surface waters are unreasonable. Testing every week is excessive, especially many weeks in advance of harvest, when food safety risk is low. Testing should only be required when risks are higher, as when irrigating two or three weeks prior to harvest, unless research proves more time is needed. Constant testing is expensive, and existing surface water data from recreational water monitoring programs show that E. coli levels are erratic from week to week over a season, and often higher than the allowed levels for irrigation. Rather than prohibit overhead irrigation when E. coli levels exceed the threshold, the focus should be on the period immediately before harvest, as most E. coli will die off after exposure to the elements. Drip irrigation water does not require testing, but it is not practical on large acreages, and there is no practical method of sanitizing the large volumes of water needed for overhead irrigation.
Agricultural water must be potable (zero coliforms) at the start of produce washing, but it is not clear if this is required throughout the washing procedure. Wash water contacts produce directly just prior to packing and sale, and it can create a cross-contamination risk if one piece of produce has pathogens on it. There is no easy way to test wash water as it is being used; however, my on-farm research suggests that double or triple washing is effective in reducing E. coli levels in wash water, as is the use of commercially available sanitizer (conventional and organically allowed products.) While the rule requires growers to have a schedule of water changing, there should also be a requirement to suppress microbial populations in wash water using either multiple rinses or the addition of sanitizer.
Biological soil amendments
The draft rule does not regulate chemical soil additives or those of nonanimal origin. Untreated soil amendments of animal origin (e.g., manure) must be applied so they do not contact covered produce during application, and after application there is a nine-month waiting period to harvest. If manure is composted, it can be applied with a 45-day waiting period (as long as it does not contact produce). Composting includes static systems that maintain aerobic conditions at 131 degrees Fahrenheit for three days, followed by curing, or turned systems that maintain aerobic conditions at a minimum of 131 degrees Fahrenheit for 15 days, with at least five turnings followed by curing. Record-keeping of compost measurements is required, and a certificate of conformance is necessary for compost producers.
A nine-month wait from spreading manure to crop harvest is not practical. This would require manure application in the fall of the year before harvest, a practice that has long been discouraged, since it can lead to loss of nitrogen and poses a threat to water quality. The current manure management standards in both GAP and the National Organic Program (NOP) are workable and provide a reasonable wait of 120 days from manure applications to harvest. A 45-day wait until harvest after compost application conflicts with the NOP standards, which don't require any waiting period.
Domestic and wild animals
The proposed rule requires risk prevention measures if there is a reasonable probability that animals will contaminate covered produce. For example, if animal intrusion occurs in a field, a farmer must not harvest produce that is visibly contaminated by animal feces or urine. The rule does not require animal fencing. Evidence of animal intrusion includes observing significant quantities of animals, animal feces or crop destruction due to grazing. If domestic animals are grazed in a field, then an "adequate waiting period" is needed between grazing and harvest. The rule does not specify a length of time, but the preamble to the rule states that the FDA would expect the waiting period to exceed nine months.
This section does not pose serious concerns. However, the waiting period to harvest produce after grazing ruminants should be no more than 120 days, as suggested for manure. A longer period is warranted for pigs. This would allow flexible use of fields for integrated livestock and crop production while still reducing risk. Record-keeping regarding monitoring of wildlife intrusions could be burdensome.
The rule requires personnel (permanent, temporary, part-time, seasonal and contracted) who handle covered produce, and their supervisors, to receive training appropriate to their duties. Training occurs upon hiring, at the beginning of each growing season (if applicable), and periodically thereafter. A trainer on the farm staff must go through a certified program in order to train other employees.
FSMA's draft produce safety rule requires weekly E. coli testing of surface water that comes in contact with crops like lettuce. A water source cannot be used if the average of five samples exceeds 126 colony- forming units (CFU) per 100 milliliters of water or if one sample is above 235 CFU; this appears to be based on recreational water standards.
It's not clear how much training is necessary. On farms with many employees of different types that come and go during the season, providing multiple trainings could be a significant expense. Having a trainer on staff is impractical for small farms with limited full-time personnel, and it is not clear where or how these people would be trained.
Health and hygiene training
Everyone must wash their hands, and must stay home if they are ill. Workers may not go to the bathroom in the fields. This is reasonable.
Equipment, tools and buildings
This section of the rule requires that equipment and tools be kept reasonably clean and buildings be constructed so that floors, walls, ceilings, fixtures, ducts and pipes can be adequately cleaned and kept in good repair. Steps should be taken to prevent contamination of covered produce, food contact surfaces, or packing materials in covered produce processing and storage areas. This is reasonable, except if greenhouses and high tunnels are considered buildings.
The proposed rule establishes both general and specific record-keeping requirements to show compliance. General record-keeping includes name and location of the farm; values and observations collected during monitoring activities; description of the produce applicable to the record (crop, variety or other identifier such as lot number); location of the growing area; and date and time an activity was performed or observed. Records must be taken at the time an activity is performed or observed, and must be dated and signed by the person doing the activity. Records to show compliance with the standards in the rule include documentation of personnel qualifications and training; agricultural water; manure and compost; and equipment, tools, buildings and sanitation. Actions taken when a standard is not met must also be documented, and a supervisor or responsible party must sign records documenting testing, monitoring, sanitizing and corrective actions.
This is an inordinate amount of record-keeping for small and medium-sized farms. It will place an unfair financial and management burden on them compared to larger farms that can better afford to assign or hire someone to focus on record-keeping.
Submitting comments to the FDA
It's a good idea to start with a brief description of your farm or your role working with farmers, and what you have already been doing to reduce food safety risks. Then describe the areas of the rule that would affect your farm and what you think the consequences would be for your business. Offer concrete suggestions and estimates of time and cost involved if you can. Comments on the two proposed rules must be submitted separately. You can use the same introduction, but be sure to cite specific parts of each rule when describing concerns or suggestion.
To submit comments online:
Produce safety rule: http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0921-0199
Preventive controls rule: http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0920-0188
If submitting online, write your comments ahead of time and save them on your computer. There is a time limit when using the Federal Register system, and you don't want to lose what you've written. If your comment is less than one page, you can copy and paste it into the comment box. If it is longer, write "see attached" in the box and upload a separate Word or PDF file with your comments. Be sure to click the "submit" button! You should then see a new screen with a confirmation number.
To submit comments by mail, send them to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Include the docket number in your comments; the produce safety rule is FDA-2011-N-0921, and the preventive controls rule is FDA-2011-N-0920. Mailed comments must arrive by the deadline, so send them a week ahead just to be sure.
The author is a vegetable and berry specialist with University of Vermont Extension based at the Brattleboro office.